Trial to Evaluate Efficacy of Magnetic Resonant Therapy (MRT) in PTSD

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

A Randomized Double-Blind Placebo-Controlled Trial to Evaluate Treatment Efficacy of EEG/ECD-Guided Magnetic Resonant Therapy in Combat Veterans With Post-Traumatic Stress Disorder (PTSD).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268084
• Other study ID #: MRT-002
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: September 2021
• Source: Wave Neuroscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in treating Post Traumatic Stress Disorder in Veterans.

Description:

This clinical trial is a prospective, randomized, double-blinded, placebo-controlled study designed to evaluate the safety and efficacy of EEG/ECG-guided magnetic resonant therapy (MRT) in combat veterans with Posttraumatic Stress Disorder. A total of 2004 subjects will be treated in two phases: double-blind and open label.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Willing and able to adhere to the treatment schedule and all required study visits.
• Any non-Active Duty Military are included.
• PCL-M > 45
• Primary diagnosis of Posttraumatic Stress Disorder rendered by the Clinician Administered PTSD Scale (CAPS)

Exclusion Criteria:

• Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated): History of open skull traumatic brain injury. History of clinically significant seizure disorder.
• Individuals with a clinically defined neurological disorder including, but not limited to: Any condition likely to be associated with increased intracranial pressure. Space occupying brain lesion. History of cerebrovascular accident. Cerebral aneurysm.
• EEG abnormalities that indicate risk of seizure, i.e., abnormal focal or general slowing or spikes during the EEG recording.
• Any type of rTMS treatment within 3 months prior to the screening visit.
• Currently under antipsychotic medication treatment.
• Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed.
• Clinically significant abnormality or clinically significant unstable medical condition that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results.
• Clinically significant medical illness, including any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning.
• Any condition which in the judgment of the investigator would prevent the subject from completion of the study.
• Inability to acquire a clinically satisfactory EEG/ECG on a routine basis.
• Grossly abnormal electrolyte or cell blood count panels suggestive of other pathology at study initiation.
• Active Duty Military are excluded.

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• Magnetic EEG/ECG-guided Resonance Therapy
A coil delivers a pulsed magnetic field to the cortex of the brain
• Sham
Sham coil simulates behavior of the intervention magnetic coil without applying the magnetic field

Locations

Country	Name	City	State
United States	Del Mar Center for Neurorestoration	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Wave Neuroscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase	Mean change in the PCL-M total scores of subjects from baseline to end of the double-blind treatment phase, compared between active and sham groups.; The Post-traumatic Stress Disorder Checklist - Military Version (PCL-M) is a 17-item metric for PTSD symptoms, as defined by the DSM-IV. Each symptom is scored on a scale from 1-5; total scores range from 17 (least symptomatic) to 85 (most symptomatic).	Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Secondary	Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Open-Label Treatment Phase	Mean change in the PCL-M total scores of subjects from baseline to end of the open-label treatment phase, compared between active and sham groups.; The Post-traumatic Stress Disorder Checklist - Military Version (PCL-M) is a 17-item metric for PTSD symptoms, as defined by the DSM-IV. Each symptom is scored on a scale from 1-5; total scores range from 17 (least symptomatic) to 85 (most symptomatic).	Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Secondary	Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Double-Blind Treatment	Mean change in the PSQI-A total scores from baseline to end of the double-blind treatment, compared between active and sham groups.; The Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) is a 7-item metric to rate sleep disturbance items that are commonly reported with PTSD. Total scores range from 0 (least severe) to 21 (most severe), where scores greater than or equal to 4 have been used to identify adults with PTSD.	Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Secondary	Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Open-Label Treatment	Mean change is the PSQI-A total scores from baseline to end of the open-label treatment, compared between active and sham groups.; The Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) is a 7-item metric to rate sleep disturbance items that are commonly reported with PTSD. Total scores ranges from 0 (least severe) to 21 (most severe), where scores greater than or equal to 4 have been used to identify adults with PTSD.	Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Secondary	Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Double-Blind Treatment	Mean change in the HAMD-17 total scores from baseline to end of double-blind treatment, compared between active and sham; The Hamilton Depression Rating Scale (HAMD-17) is a 17-item metric to rate subjects on severity of depressive symptoms. Total scores range from 0-52, with higher scores indicating more severe symptoms; a score of 0-7 is generally accepted to be within normal range (or in remission), while a score of 20 or greater indicates moderate to severe depression.	Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Secondary	Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Open-Label Treatment	Mean change in the HAMD-17 total scores from baseline to end of open-label treatment, compared between active and sham groups.; The Hamilton Depression Rating Scale (HAMD-17) is a 17-item metric to rate subjects on severity of depressive symptoms. Total scores range from 0-52, with higher scores indicating more severe symptoms; a score of 0-7 is generally accepted to be within normal range (or in remission), while a score of 20 or greater indicates moderate to severe depression.	Baseline (Day 0) and End of Open-Label Treatment (Week 4)
Secondary	Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment	Mean change in each WHO-QOL domain score from baseline to end of treatment, compared between active and sham groups.; The World Health Organization's Quality of Life Index - BREF Version (WHO-QOL) is a metric used to establish the subject's quality of life in four domains: physical health (D1), psychological health (D2), social relationships (D3), and environmental health (D4). Higher scores indicate a more positive quality of life; D1 has a score range of 7-35, D2 has a range of 6-30, D3 has a range of 3-15, D4 has a range of 8-40.	Baseline and End of Double-Blind (Week 2)
Secondary	Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment	Mean change in each WHO-QOL domain score from baseline to end of open-label treatment, compared between active and sham groups.; The World Health Organization's Quality of Life Index - BREF Version (WHO-QOL) is a metric used to establish the subject's quality of life in four domains: physical health (D1), psychological health (D2), social relationships (D3), and environmental health (D4). Higher scores indicate a more positive quality of life; D1 has a score range of 7-35, D2 has a range of 6-30, D3 has a range of 3-15, D4 has a range of 8-40.	Baseline (Day 0) and End of Open-Label (Week 4)